On these related topics

CLEVELAND, April 24 /PRNewswire/ — RSB Spine, LLC, a privately held
medical device company focused on developing innovative spinal implants,
announced today that the U.S. Food and Drug Administration has approved its
510(k) application to permit marketing of the InterPlate™ Vertebral Body
Replacement System for use without supplemental fixation. The new
indication will allow RSB Spine to market the product as an anterior fusion
device, without the need for additional posterior implant support.
Submissions for cervical and lumbar interbody indications will follow, as
well as new product designs based on the InterPlate platform.

The InterPlate™ VBR is a unique spinal implant designed to
facilitate rapid fusion and is used in conjunction with graft material to
fuse two or more vertebrae together. Spinal fusion is one of the most
common procedures performed by neurosurgeons and orthopedic spine surgeons.

Robert S. Bray Jr., M.D., is the inventor of the InterPlate™ and has
performed over 7,500 spine surgeries. He is the director of St. Johns Spine
Institute in Santa Monica, CA, and the Founding Director and CEO of
D.I.S.C., a state-of-the-art outpatient surgery center in Marina del Rey,
CA. Dr. Bray said: “This will allow the InterPlate™ VBR to be used in
those patients where a less invasive, anterior approach is selected, in
conjunction with a standalone implant. Compared to use with posterior
supplemental fixation, the patient will recover more rapidly, and hospitals
will realize significant cost savings. I am excited about a dynamic, low
profile device with screw back out prevention being available for this
application.” Dr. Bray has invented a number of other commercially
successful medical devices.

John A. Redmond, Chief Executive Officer of RSB Spine, added: “The
response to this product has been tremendous, and we are in negotiations
with several top distributors who are very anxious to start selling the
InterPlate™ and the new devices we are developing based on the
InterPlate™ platform. We expect to show a very steep sales ramp starting
in June, when we will have enough inventory to meet demand. We also expect
to introduce two additional products later this summer.”